Label: FLAWLESS BY SONYA ALOE BB CREME NUDE- titanium dioxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 13, 2014

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  • ACTIVE INGREDIENT


    Active Ingredient
    		Purpose
    Titanium Dioxide 7%...............
    		Sunscreen

  • Uses

    • helps prevent sunburn
  • WARNINGS

    Warnings

    Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn not skin cancer or early skin aging.

    For external use only



    Do not use on damaged or broken skin


    When using this product keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if rash occurs



    Keep out of reach of children.
    If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions


    • apply generously and evenly 15 minutes before sun exposure
    • reapply at least every 2 hours
    • use a water-resistant sunscreen if swimming or sweating
    • children under 6 months of age: Ask a doctor
  • INACTIVE INGREDIENT

    Inactive Ingredientswater/aqua/eau, dimethicone, coco-caprylate, caprylic/capric triglyceride, talc, dimethicone/vinyl dimethicone crosspolymer, titanium dioxide (CI 77891), cetyl peg/ppg-10/1 dimethicone, propanediol, sorbitan olivate, glyceryl tribehenate/isostearate/eicosandioate, iron oxides (CI 77491, CI 77492, CI 77499), stearalkonium hectorite, mica, alumina, sodium chloride, phenoxyethanol, tropolone, triethoxycaprylylsilane, sodium dehydroacetate, propylene carbonate, hydrogen dimethicone, aloe barbadensis leaf extract, fragrance/parfum, spilanthes acmella flower extract, olea europaea (olive) leaf extract, aluminum hydroxide, tin oxide, trisodium ethylenediamine disuccinate, alcohol, maltodextrin, olea europaea (olive) fruit extract.

  • Other Information


    • protect the product in the enclosed container from excessive heat and direct sun
  • QUESTIONS

    Questions or comments?Call 1-888-440-2563, Monday-Friday, 9:00 am to 4:00 pm PT.

  • PRINCIPAL DISPLAY PANEL

    label for bb creme nude box
    label for bb creme nude tube
  • INGREDIENTS AND APPEARANCE
    FLAWLESS BY SONYA ALOE BB CREME  NUDE
    titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11697-371
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.1500 g  in 45.0000 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    TALC (UNII: 7SEV7J4R1U)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 3) (UNII: G300307ZXP)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    GLYCERYL TRIBEHENATE/ISOSTEARATE/EICOSANDIOATE (UNII: 3Y9NJ5Z7E5)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    MICA (UNII: V8A1AW0880)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TROPOLONE (UNII: 7L6DL16P1T)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ACMELLA OLERACEA FLOWER (UNII: 2794N5KM0K)  
    OLEA EUROPAEA BARK (UNII: 4BN4L34UKC)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
    ALCOHOL (UNII: 3K9958V90M)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    BLACK OLIVE (UNII: 2M6QWV94OC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11697-371-021 in 1 CARTON
    1NDC:11697-371-0145 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/12/2014
    Labeler - Aloe Vera of America, Inc. (049049463)
    Registrant - Aloe Vera of America, Inc. (049049463)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aloe Vera of America, Inc.049049463manufacture(11697-371)
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